Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the efficacy of e-TNS with the Cefaly® device as an acute treatment for a migraine attack. This open clinical trial will study the acute treatment of migraine using the Cefaly® device, prior to development of a sham-controlled trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | 60 minutes of CEFALY stimulation as acute treatment of an on-going attack |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEFALY | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of pain intensity at 1 hour (VAS score) | Mean change in intensity of pain at 1 hour when compared to baseline, measured on a visual analog scale (VAS) ranging from 0 to 11 | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Change of pain intensity at 2 hours (VAS score) | Mean change in intensity of pain at 2 hours when compared to baseline, measured on a visual analog scale (VAS) ranging from 0 to 11 | 2 hours |
| Patients with no need of medication at 2 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Headache Center | New York | New York | 10019 | United States |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Percentage of patients not having required rescue medication after 2 hours
| 2 hours |
| Patients with no need of medication at 24 hours | Percentage of patients not having required rescue medication after 2 hours | 24 hours |
| D009422 | Nervous System Diseases |